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U.S. Department of Health and Human Services

Enforcement Report - Week of December 11, 2013

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Event Detail

Event ID 66158
Product Type Biologics
Status Completed
Recalling Firm Blood Systems, Inc
City Fargo
State ND
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-13
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern North Dakota; California

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Red Blood Cells Leukocytes Reduced W042510003654V; W042509082594Y; W0425090525442; W0425080449784; W042508029674K; 302980594; Class II Blood products, collected from an ineligible donor, were distributed. 6 units B-0047-14
Red Blood Cells (Apheresis) Leukocytes Reduced W042510071719M; W042510071719M; Class II Blood products, collected from an ineligible donor, were distributed. 2 units B-0046-14
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